MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER DUCT OCCLUDER; OCCLUDER, PATENT DUCTUS, ARTERIOSUS

Catalog Number 9-PDA-005

Device Problems Difficult to Fold, Unfold or Collapse (1254); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/15/2023

Event Type  malfunction  

Event Description

It was reported that a 8-6mm amplatzer duct occluder was selected for implant on (b)(6) 2023 using a 6f amplatzer torqvue delivery system.During implant the device was observed to take on a cobra shape.The physician thought the device may return to its original shape under tension and released the device from the delivery system.The device maintained the cobra shape.There were no interactions with cardiac structures.There were no angulations or kinks noted in the delivery system.There were no clinically significant delays during the procedure.There were no adverse effects to the patient.The patient status was stable.

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

An event of device deformity during implant was reported.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received, the root cause of the reported event could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.Information from field indicated that it was thought the device may return to its original shape under tension and released the device from the delivery system.The device maintained the cobra shape.Please note that per the instructions for use, "warning: do not release the occluder from the delivery cable if: - more than 3 mm of the occluder extend into the pulmonary artery.- the occluder extends more than halfway across the pulmonary artery.- left pulmonary artery flow is more than 3 m/s or more than 75% greater than the velocity before cardiac catheterization.- the occluder does not conform to its original configuration.- the occluder¿s position is unstable.If any of these conditions exists, recapture the occluder by advancing the sheath over the occluder.Redeploy the occluder.If the occluder's configuration or position remains unsatisfactory, recapture and replace the occluder with a new one."na.

• Brand Name: AMPLATZER DUCT OCCLUDER
• Type of Device: OCCLUDER, PATENT DUCTUS, ARTERIOSUS
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG# 2135147; 5050 nathan ln n; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18470546
• MDR Text Key: 332410375
• Report Number: 2135147-2024-00147
• Device Sequence Number: 1
• Product Code: MAE
• UDI-Device Identifier: 00811806011127
• UDI-Public: 00811806011127
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: P020024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9-PDA-005
• Device Lot Number: 9080912
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 9-ITV06F180/80
• Patient Age: 7 YR
• Patient Sex: Female
• Patient Weight: 21 KG